Additional Authorizations and Compliance Regulations

Additional Authorizations
& Compliance Regulations

The Use of Human Subjects in Research:

If human subjects are to be included as a part of a proposed project, the Institutional Review Board for the Protection of Human Subjects in Research must review and approve the proposed protocol for the use of human subjects in research. Approval by this committee is required PRIOR to initiating any research involving human subjects, regardless of whether grant support is involved.

Faculty members can find the forms listed at the website given below and then turn a copy of the IRB in with their proposal. The faculty member must turn the original form over to one member on the IRB committee other than the Chair. He acts as the approver, not as a reviewer. Only the Chair of the IRB can determine whether the proposed research is exempt, or may be eligible for expedited review.

However, the Department of Health and Human Services has created this website to help researchers determine if their proposal may be exempt, expedited or requires a full board review:
HHS Human Subject Regulations Decision Charts

The University's IRB form is found on the OSRP Forms page, under the compliance tab.

Animal Use and Welfare:

If animals, whether laboratory, domestic, or wild, are involved in a research project, the proposed protocol for the use and care of animals in research must be reviewed and approved by the Institutional Animal Care and Use Committee (IACUC), regardless of whether grant support is involved. IACUC approval is required PRIOR to initiating any research involving animals.

The IACUC Protocol Form is available on the ORSP Forms page, under the compliance tab. Be sure to include the correct category according to USDA regulations, also downloadable from the ORSP Forms page, under the compliance tab.

Radioactive Materials:

The University Engineering Campus Planning Office & Office of Campus Safety must review a research study involving radioactive materials, or exposure of personnel and/or subjects to radioactivity of any kind.

The Project Hazard Assessment Form is available on the ORSP Forms page, under the compliance tab.

Biosafety, Recombinant DNA, Hazardous Materials, Select Agents, and Controlled Substances:

If hazardous material, select agents or controlled substances are involved in the research or is a byproduct, the Office of Campus Safety must be notified. The ORSP will provide Campus Safety with a copy of the state and federal licenses for controlled substance. Hazardous materials must be identified on the Project Hazard Assessment Form, which is available on the ORSP Forms page, under the compliance tab.

If radioactive or hazardous materials will be a byproduct of any research project, funds must be requested in the proposal or identified with an existing account number for the disposal of this material. If the proposed research involves recombinant DNA, review and approval by the Texas A&M University Review Board is required.

The Texas A&M System Office of Research Compliance outlines the responsibilities, procedures, review, and approval processes.

Patents and Inventions

The Intellectual Property Policy and Regulations of the Texas A&M University System (17) covers inventions, discoveries, trade secrets, technology, and computer software developed by faculty, staff, and students using university facilities. The TAMUS Technology Commercialization Office will assist with legal and business matters involving protection and commercialization of intellectual property. A disclosure of all newly created intellectual property should be submitted through Office of Research and Sponsored Programs for TAMUS review.

Texas A&M System Technology Commercialization for Inventors

Additional Office/Lab Space or Renovation:

If additional space or renovations will be required to fulfill the scope of work stated in the proposal, a description of the additional space and any cost for renovations must be attached to the Proposal Authorization Forms.

If costs are to be assigned to the university, the source of these matching funds must be identified prior to submission. Renovations to facilities may require that the facilities be brought into compliance with the Americans with Disabilities Act (ADA) guidelines. The University Engineering and Planning Office must provide the cost estimate for a proposal. Visit the Physical Plant's website to learn more.

Conflict of Interest:

The University has a responsibility to manage, reduce, or eliminate any actual or potential conflicts of interest that may arise due to financial or other personal interests of an investigator. Therefore, the university requires that investigators disclose any significant financial interest that might create a real or potential conflict of interest in relation with a sponsored project. The Project Director/Principal Investigator’s signature on the TAMUK Institutional Authorization Form indicates that no conflict of interest exists. If a conflict of interest does exist, the PD/PI must attach a signed statement outlining the nature of the conflict of interest

Executive Order:

The proposal must be in the ORSP office five days in advance if they are covered by the Executive Order (EO). The PI or ORSP can ask the Single Point of Contact (SPOC) if they need to see an Executive order. If they decide to waive that need than ORSP will need the form from them stating they are waving this requirement. The Executive Order must include a breakdown on the proposal budget.

Excess of Time and Effort:

Sometimes a PI will be involved in multiple projects that, with the new proposal, will exceed 100% of the work time. Any proposal that suggests a time and effort that exceeds 100% of the PI's work time must have institutional approval which includes a signed statement from the Provost.

This page was last updated on: April 28, 2016